Loading…
Attending this event?
Tuesday, June 18 • 8:00am - 9:00am
#211: PMDA Town Hall

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-566-L04-P; CME 1.00; RN 1.00

PMDA strives and implements various supports to promote regulatory sciences and accelerate product developments based on “4Fs” concept of priorities. In this session, PMDA will share the latest information on its policies and initiatives.

Learning Objectives

Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Describe how to develop medical products in Japan; Discuss issues on medical products regulation with senior PMDA officials.

Chair

Daisuke Tanaka, PhD

Speaker

PMDA Update
Daisuke Koga, MSc, RPh

Industry Update
Atsushi Tsukamoto, PhD, MSc

Panelist
Yoshiaki Uyama, PhD, RPh


Speakers
avatar for Daisuke Tanaka

Daisuke Tanaka

Office Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Tanaka joined the Ministry of Health, Labour and Welfare (MHLW) in April 2001 and was involved in orphan drug designation and new drug approval as well as amendment of the Pharmaceutical Affairs Law. Subsequently, he worked in several organisations including European Medicines... Read More →
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices... Read More →
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Head is Therapeutic Area Strategies, Daiichi Sankyo, United States
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
avatar for Cynthia Verst

Cynthia Verst

President, R&D Solutions D&DI; 2023 President, IQVIA, United States
Dr. Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. She is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session